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ACTION - Anticoagulation Treatment Influence on Post-operative Patients

This study has been withdrawn prior to enrollment.
(Study replaced by an observational study)
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187304
First received: September 15, 2005
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

The primary objective of this study is to compare two different regimens of therapy, AVK and ASA (aspirin), in the early postoperative period after aortic valve replacement with SJM Epic™ or SJM Epic™ Supra Porcine Bioprosthetic Heart Valve by establishing the adverse event free survival rate at 3 month post intervention follow-up of the 2 groups(with special focus on thromboembolic events and bleedings).


Condition Intervention Phase
Heart Valve Disease
Device: Aortic valve replacement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anticoagulation Treatment Influence on Post-operative Patients -Action SJM EPIC Trial

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Enrollment: 0
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient requires, for the first time, isolated aortic valve replacement (pacemaker insertion is allowed)
  2. Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements.
  3. Patient is of legal age in the host country
  4. The patient is in sinus rhythm before implantation

Exclusion Criteria:

  1. Patient already has a prosthetic valve, other than the valve being replaced at this time.
  2. Patient requires double valve implantation
  3. Patient requires concomitant CABG
  4. Patients requires intra aortic balloon pump at intervention
  5. Patient has a medical condition which contraindicates implantation of the SJM Epic and/or SJM Epic Supra Porcine Bioprosthetic Heart Valve (e.g. patient on dialysis)
  6. Patient requires ASA or AVK therapy, i.e. not suitable for randomization
  7. Patient is pregnant or nursing.
  8. Patient is affected by active endocarditis.
  9. Patient is affected by aortic dissection.
  10. Patient has history of cerebral ischemia
  11. Patient is affected by coagulopathy, history of GI bleeding or increased bleeding risk
  12. Patient is affected by peripheral vascular disease requiring treatment
  13. Patient has previous chronic anticoagulation therapy
  14. Patient is allergic to ASA and/or AVK
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187304

Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Jean-Phillippe Verhoye, MD CHU Pontchaillou Rennes France
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00187304     History of Changes
Other Study ID Numbers: CS04012TV
Study First Received: September 15, 2005
Last Updated: June 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Heart Valve Diseases
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 23, 2014